AquaShield System CO2- Fujifilm— 510(k) K173650
Substantially EquivalentUnited States Endoscopy Group, Inc.
FDA 510(k) clearance K173650 for AquaShield System CO2- Fujifilm, Substantially Equivalent on 2018-01-05. Applicant: United States Endoscopy Group, Inc..
Clearance details
- Applicant
- United States Endoscopy Group, Inc.
- Product code
- Code FEQ
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Mentor, OH, US
Adverse events under product code FEQ
product code FEQ- Malfunction
- 1,135
- Total
- 1,135
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.